Otc - Active Ingredient
Benzyl Alcohol 0.27%
Zinc Chloride 0.15%
Orajel Toothache Rinse Liquid
FDA Label NDC 10237-764
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Orajel Toothache Rinse (NDC 10237-764). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral pain reliever
Oral astringent
Indications & Usage
Use for temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat
Warnings
Warnings
Do not use this product for more than 7 days unless directed by a dentist or healthcare provider
Otc - When Using
When using this product • do not swallow • do not exceed recommended dosage
Otc - Stop Use
Stop use and see your physician promptly if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days • allergic reaction occurs • sore thoat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions
• remove imprinted safety seal from bottle cap
• to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.
Adults and children 2 years of age or over:
Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider
Children under 12 years of age:
Should be supervised in the use of this product
Children under 2 years of age:
Consult a dentist or healthcare provider
Other Information • cap tightly • keep away from heat or direct sunlight • do not use if safety seal is broken or missing
Inactive Ingredient
Inactive Ingredients alcohol (4.1% by volume), blue 1, disodium pyrophosphate, menthol, methyl salicylate, poloxamer 338, polysorbate 20, sodium benzoate, sodium saccharin, sorbitol, tetrasodium pyrophosphate, water
Otc - Questions
Questions or comments calls us at 800 952 5080 Monday through Friday 9 to 5 ET or visit our website at www orajel com
Package Label.Principal Display Panel
#1
ORAL PAIN RELIEVER
BRAND FOR TOOTHACHE
NON-NUMBING RELIEF!
Orajel™
For TOOTHACHE
Analgesic & Astringent Rinse
Provides All-Over Oral Pain Relief
Soothes Irritated Gums
Cleans Affected Area
Kills Odor-Causing Bacteria
Soothing
Mint
Rinse
ORAL PAIN RELIEVER/
ASTRINGENT
16 FL OZ (473.2 mL)
Da2011186_ojlbf-43001-02_72013520 (Da2011186 Ojlbf 43001 02 72013520)
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